FDA.reportPublic FDA data

Owl Night Guard

Primary DI
00860014754609
Brand
Owl Night Guard
Company
OWL DENTAL LAB INC
Model
1
Device description
Owl Hybrid Night Guard
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription
OBRMouthguard, Over-The-Counter
OCOMouthguard, Migraine/Tension Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU
OBRMouthguard, Over-The-CounterUnknownU
OCOMouthguard, Migraine/Tension HeadacheUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253641000Owl Night GuardOwl Dental Lab, Inc.2026-02-26OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014754609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014754609008600147546098600147546090860014754609

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125242583
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014754616Owl Night Guard12026-03-05
00860014754623Owl Night Guard12026-03-05
00860014754630Owl Impression Kit12026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314788Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
00810036604284Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604291Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604307Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604314Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604901Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604932Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036606783America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036607353America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036601245RestwellDental Choice Holdings LLCOBR2026-10-23
00810036601801Wake RightDental Choice Holdings LLCOBR2026-10-23
00810036604185Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604192Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604208Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604246Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604253Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23